Positive
FDA approved assay
Manufacturer – Dako Cytomation
Carpinteria, CA
The EGFR assay is a qualitative immunohistochemical system
to identify
epidermal growth factor receptor expression in normal and neoplastic tissues
routinely and properly fixed for histological evaluation. EGFR is an aid
in identifying colorectal cancer patients eligible for treatment with
ERBITUX (cetuximab).
Epidermal growth factor receptor is a 170kD transmembrane receptor encoded by the human HER1 gene. The EGFR protein contains an extracellular ligand binding domain, a transmembrane region and an intracellular domain with intrinsic protein-tyrosine kinase activity. EGFR is homologous to other members of the EGF receptor/erbB family including HER2/erbB2 or neu, HER3/erbB3 and HER4/erbB4. The EGFR protein is expressed by a variety of normal cells including many epithelial cell types and tumors derived from them. Non-epithelial cell types that express EGFR include smooth muscle, fibroblasts and nerve.
Tissue specimens must be handled and properly fixed in
the following
Fixatives for the best preservation possible:
10% neutral buffered formalin
10% unbuffered formalin
Acetic Formalin Alcohol (AFA)
Formalin substitutes should not be used for tissue fixation.
incomplete peripheral staining. The IHC staining pattern is frequently
heterogeneous, exhibiting various staining intensities within a single
neoplasm. Staining has been seen in the cytoplasm and extracellular
spaces. Membrane staining should be used as the evaluable structure
above background level.
tumor cell membranes above background level, whether it is complete or
incomplete peripheral staining.
Dako Cytomation
Carpinteria, CA.
